Sun Pharma gets epilepsy drug licence for US market

Chennai, (IANS) Sun Pharmaceutical group on Monday announced the licensing of ELEPSIA XR drug by Sun Pharma Advanced Research Company Ltd (SPARC) to a subsidiary of Sun Pharmaceutical Industries Ltd for the US market.

In a statement, Sun Pharma said SPARC will licence ELEPSIA XR (Levetiracetam Extended Release tablets) to a wholly-owned subsidiary for the US market.

SPARC will receive an up-front payment of $10 million from Sun Pharma apart from certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XR.

According to Sun Pharma, ELEPSIA-XR was approved by US Food and Drug Administration (USFDA) in March 2015.

However, in September 2015, SPARC received a complete response letter (CRL) from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility, Halol site of Sun Pharma, was not acceptable on the date of approval.

Subsequently Sun Pharma has undertaken a detailed remediation at Halol for restoring GMP – Good Manufacturing Practice, compliance status for the site.

“ELEPSIA XR is designed as a novel once-a-day formulation of Levetiracetam using SPARC’s proprietary Wrap Matrix technology,” Anil Raghavan, CEO, SPARC was quoted as saying in the statement.

It is designed to reduce pill burden and help improve convenience and compliance in these patients.

“If and when the USFDA reapproves the ELEPSIA XR application, Sun Pharma’s significant US presence will help SPARC in commercialising this important product for patients in the US market,” Raghavan added.